Introduction

Uses for Pravachol

Prevention of Cardiovascular Events

Adjunct to nondrug therapies (e.g., dietary management) in patients with hypercholesterolemia without clinical evidence of CHD to reduce the risk of MI, to reduce the risk of undergoing myocardial revascularization procedures, and to reduce the risk of cardiovascular mortality (with no increase in death from noncardiovascular causes).11271

Adjunct to nondrug therapies (e.g., dietary management) in patients with clinical evidence of CHD to reduce the risk of total mortality by reducing coronary death, to reduce the risk of MI, to reduce the risk of undergoing myocardial revascularization procedures, and to reduce the risk of stroke or TIA.171

Adjunct to nondrug therapies (e.g., dietary management) in patients with clinical evidence of CHD to slow the progression of coronary atherosclerosis.113141671 Has been shown to slow the progression and/or induce regression of atherosclerosis in a few patients without clinical evidence of CHD† who had mild to moderate elevations of LDL-cholesterol concentrations.61

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Intensive antilipemic therapy (atorvastatin 80 mg daily) shown to be more effective than moderate antilipemic therapy (pravastatin 40 mg daily) in reducing the risk of cardiovascular events in patients hospitalized for acute coronary syndrome (16% reduction in composite risk of death or major cardiovascular events for atorvastatin compared with pravastatin regimen).69 Intensive antilipemic therapy also more effective in slowing progression of coronary atherosclerosis in patients with CHD.70

Dyslipidemias

Adjunct to nondrug therapies (e.g., dietary management) in adults to decrease elevated serum total and LDL-cholesterol, apolipoprotein B (apo B), and triglyceride concentrations and to increase HDL-cholesterol concentrations in the management of primary hypercholesterolemia or mixed dyslipidemia (Fredrickson type IIa or IIb).12351771

Adjunct to dietary therapy and lifestyle modification in the management of heterozygous familial hypercholesterolemia in children ≥8 years of age who, despite an adequate trial of dietary management, have a serum LDL-cholesterol concentration of ≥190 mg/dL or a serum LDL-cholesterol concentration of ≥160 mg/dL and either a family history of premature cardiovascular disease or ≥2 other cardiovascular risk factors.171

Adjunct to nondrug therapies (e.g., dietary management) in the treatment of primary dysbetalipoproteinemia (Fredrickson type III) in patients who do not respond adequately to diet.171

Reduction of total and LDL-cholesterol concentrations in patients with hypercholesterolemia associated with or exacerbated by diabetes mellitus† (diabetic dyslipidemia),5162 cardiac† or liver† transplantation,1963 or nephrotic syndrome† (nephrotic hyperlipidemia).20

Pravachol Dosage and Administration

General

Patients should be placed on a standard lipid-lowering diet before initiation of pravastatin therapy and should remain on this diet during treatment with the drug.1

Special Populations

Hepatic Impairment

Use with caution in patients who consume substantial amounts of alcohol, have a recent (<6 months) history of liver disease, or exhibit manifestations of liver disease (e.g., unexplained increases in aminotransferase concentrations, jaundice).171

Warnings/Precautions

Fetal/Neonatal Morbidity and Mortality

Administer to women of childbearing age only when such patients are highly unlikely to conceive and have been informed of the potential hazards.1 If the patient becomes pregnant while taking the drug, immediately discontinue therapy and apprise the patient of the potential hazard to the fetus.171

Musculoskeletal Effects

Rhabdomyolysis (characterized by muscle pain or weakness with marked increases [>10 times the ULN] in serum CK concentrations and increases in Scr [usually accompanied by brown urine and urinary myoglobinuria]) with acute renal failure secondary to myoglobinuria has been reported.1

Obtain serum CK concentrations and compare with baseline concentrations in patients presenting with musculoskeletal symptoms suggestive of myopathy; because hypothyroidism may be a predisposing factor, thyrotropin (thyroid-stimulating hormone, TSH) concentrations also should be obtained in such patients.

Consider myopathy in any patient with diffuse myalgias, muscle tenderness or weakness, and/or marked elevation in CK.71 Discontinue if serum CK concentrations increase markedly or if myopathy is diagnosed or suspected.1

Monitor patients weekly if myalgia (muscle pain, tenderness) is present with either no CK elevation or a moderate elevation (3–10 times the ULN) until manifestations improve; discontinue if manifestations worsen.

Dosage reduction or temporary discontinuance may be prudent in patients with muscle discomfort and/or weakness in the presence of progressive elevation of CK concentrations on serial measurements.

Temporarily withhold therapy in any patient experiencing an acute or serious condition predisposing to the development of renal failure secondary to rhabdomyolysis (e.g., sepsis; hypotension; major surgery; trauma; severe metabolic, endocrine, or electrolyte disorders; uncontrolled seizures).1

Perform liver function tests before initiation of therapy and as clinically indicated (e.g., presence of manifestations suggestive of liver damage201 ).71 Although manufacturer previously recommended more frequent monitoring, FDA concluded that serious statin-related liver injury is rare and unpredictable, and that routine periodic monitoring of liver enzymes does not appear to be effective in detecting or preventing serious liver injury.200

If serious liver injury with clinical manifestations and/or hyperbilirubinemia or jaundice occurs, promptly interrupt pravastatin therapy.71 If an alternate etiology is not found, do not restart pravastatin.71

Caution advised if a statin or another antilipemic agent is used concomitantly with drugs that may decrease concentrations or activity of endogenous steroid hormones (e.g. ketoconazole, spironolactone, cimetidine).71

Cognitive Impairment

Generally nonserious and reversible, with variable times to symptom onset (1 day to years) and resolution (median of 3 weeks following discontinuance of therapy).71200 Not associated with fixed or progressive dementia (e.g., Alzheimer’s disease) or clinically important cognitive decline.200 Not associated with any specific statin, patient's age, statin dosage, or concomitant drug therapy.200

FDA states that cardiovascular benefits of statins outweigh the small increased risk of cognitive impairment.200

Role as Adjunct Therapy

Prior to institution of antilipemic therapy, vigorously attempt to control serum cholesterol by appropriate dietary regimens, weight reduction, exercise, and treatment of any underlying disorder that might be the cause of lipid abnormality.1

Specific Populations

Pregnancy

Category X.1 (See Contraindications and also see Fetal/Neonatal Morbidity and Mortality under Cautions.)

Lactation

Small amounts distributed into milk.1 Use contraindicated in nursing women; women who require pravastatin therapy should not breast-feed their infants.71

Pediatric Use

Safety and efficacy not established in children <8 years of age.1 Advise adolescent girls to use effective and appropriate contraceptive methods during therapy to reduce the likelihood of unintended pregnancy.1

Geriatric Use

No substantial differences in safety or efficacy relative to younger adults.1

Use with caution, since age ≥65 years is a predisposing factor for myopathy.71

Hepatic Impairment

Use with caution in patients who consume substantial amounts of alcohol, have a recent (<6 months) history of liver disease, or exhibit manifestations of liver disease (e.g., unexplained increases in aminotransferase concentrations, jaundice).71

Bioavailability

Evening administration of the drug is associated with a decrease in the extent of absorption;1 however, the antilipemic activity remains unchanged and may be superior to the activity achieved with morning administration.1

Onset

A therapeutic response to pravastatin is usually apparent within 1 week after initiating therapy, with a maximal response occurring within 4 weeks.1

Food

Food appears to reduce the systemic bioavailability of pravastatin;1 however, antilipemic effects are similar whether pravastatin is administered with or 1 hour prior to meals.1

Importance of informing patients about risks, especially rhabdomyolysis, associated with statins alone or combined with other drugs.1 Importance of patients promptly reporting muscle pain, tenderness, or weakness, particularly if accompanied by malaise or fever.1

Importance of informing clinician of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1

Importance of informing patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

* available from one or more manufacturer, distributor, and/or repackager by generic (nonproprietary) name

Pravastatin Sodium

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets

10 mg (of pravastatin)*

Pravachol

Bristol-Myers Squibb

Pravastatin Sodium Tablets

20 mg (of pravastatin)*

Pravachol

Bristol-Myers Squibb

Pravastatin Sodium Tablets

40 mg (of pravastatin)*

Pravachol

Bristol-Myers Squibb

Pravastatin Sodium Tablets

80 mg (of pravastatin)*

Pravachol

Bristol-Myers Squibb

Pravastatin Sodium Tablets

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

43. Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults. Summary of the second report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel II). JAMA. 1993; 269:3015-23. [IDIS 315201] [PubMed 8501844]

64. Expert Panel on Detection, Evaluation, and Treatment of high Blood Cholesterol in Adults. Executive summary of the third report of the National Cholesterol Education Program (NCEP) Expert Panel on Detection, Evaluation, and Treatment of high Blood Cholesterol in Adults (Adult Treatment Panel III). JAMA. 2001; 285:2486-97. [IDIS 464555] [PubMed 11368702]

72. Panel on Antiretroviral Guidelines for Adults and Adolescents, US Department of Health and Human Services (DHHS). Guidelines for the use of antiretroviral agents in HIV-1-infected adults and adolescents (July 5, 2012). Updates available at DHHS AIDS Information (AIDSinfo) website.

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